Medical Safety Officer - Electrophysiology

Role Summary

Medical Safety Officer responsible for medical safety stewardship for Medical Device products, with an independent medical voice and collaboration across R&D, Quality, Regulatory, Clinical, Medical Affairs, Epidemiology and Safety sciences. The role focuses on risk management throughout the product lifecycle, with primary responsibility for Electrophysiology, Cardiac Imaging, Structural Heart, and Reprocessing.

Responsibilities

• Assess product risk-benefit and offer medical input/review to Risk Management Reports, Product Issue assessments/Health Hazards Evaluations, Clinical Evaluation Reports, and Product Safety Surveillance Plans, including risk categorization of product families; review and input on mitigations, labeling, and safety training materials.
• Interpret post-marketing safety data, aggregate complaint data, individual case safety reports, and literature with possible safety data.
• Contribute to design and interpretation of safety-related studies and SSP activities.
• Represent Medical Safety in product reviews during development.
• Evaluate medical impact of manufacturing and design issues; oversee and guide Medical Safety performance of products.
• Monitor external sources/trends and identify emerging issues (e.g., complaint/MDR/MDV trends, regulatory/market trends, literature).
• Advise on failure investigations and provide medical opinion on reportability; gather medical information/data from customers/users as required.
• Review safety-related information to customers to prevent repeat adverse events and complaints; discuss AE investigations with healthcare professionals as requested.
• Act as medical representative in field-action decisions and evaluate effectiveness of field safety actions; ensure consistency in medical evaluations and safety decisions.
• Deploy standard practices in coordination with MD CMO; ensure appropriate metrics for patient safety processes.
• Contribute to definition of product harms and hazard lists and criteria for reportability; act as subject-matter-expert in audits and regulatory interactions.
• Review and approve safety-related reports and filings; respond to regulatory bodies, clinicians, and patients as needed; coordinate with Regional Safety Officers for timely information sharing.

Qualifications

• Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent degree.
• Minimum of 3 years clinical or research experience.
• Relevant experience or specific training in Cardiovascular field.
• Ability to use common computer programs (Microsoft Office: Outlook, Word, Excel, PowerPoint).
• Knowledge of basic statistical techniques and epidemiological principles.
• Knowledge of pre-clinical or clinical research concepts.

• Specialties: Electrophysiology, Interventional Cardiology, Cardiology, Interventional Radiology.
• Experience in risk evaluation and mitigation; medical device and/or pharmaceutical industry experience in healthcare or device industry.
• Clinical study/research experience; experience working with senior leadership within a global healthcare company.
• Advanced statistical knowledge (e.g., multivariate data analysis); knowledge of local and international Medical Device regulations.

Skills

• Clinical Operations
• Compliance Management
• Consulting
• Design Mindset
• Developing Others
• Leadership
• Medicines and Device Development and Regulation
• Operational Excellence
• Quality Control (QC)
• Research Ethics
• Risk Compliance
• Risk Management
• Safety Investigations
• Safety-Oriented
• Serious Adverse Event Reporting
• Standard Operating Procedure (SOP)
• Succession Planning
• Surveillance

Education

• Doctor of Medicine (MD) or Doctor of Osteopathy (DO) or equivalent degree.